Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 SEP 2022 To 12 OCT 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- November 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- July 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- March 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- 1-amino-N-[6-cyano-5-(trifluoromethyl)-3- pyridyl]cyclobutanecarboxamide
- Cas Number:
- 1950587-17-3
- Molecular formula:
- C12H11F3N4O
- IUPAC Name:
- 1-amino-N-[6-cyano-5-(trifluoromethyl)-3- pyridyl]cyclobutanecarboxamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: JNJ-63632283-AAA (T003665)
- Physical state: solid (powder)
- Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: 22BN0551
- Expiry date: 28 April 2023 (retest date)
- Purity test date: 13 May 2022 (certificate of analysis release date)
- Physical Description: Off-white powder
- Purity: 98.3%
- Purity correction factor: no correction factor required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Results and discussion
Water solubility
- Key result
- Water solubility:
- 0.102 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- pH:
- 7.4
- Details on results:
- Preliminary test
The content of test material dissolved in double distilled water was 0.109 g/L.
Main study
The maximum difference of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the test material is given as the mean value of the analyzed concentrations. No test material was detected in the pre-treated sample from the blank water mixture.
Any other information on results incl. tables
The results for the samples taken at 24, 48 and 72 hours are given in the table below
Water Solubility of the Test Material
Stirring time | Analyzed concentration | Mean | Maximum difference | pH |
|
|
|
|
|
24 | 0.102 | 0.102 | 1.6 | 7.4 |
|
|
|
|
|
48 | 0.102 |
|
| 7.4 |
|
|
|
|
|
72 | 0.101 |
|
| 7.4 |
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- The flask method was applied for the determination of the water solubility of JNJ-63632283-AAA (T003665).
The water solubility of the test material at 20°C was 0.102 g/L.
The pH of the aqueous samples was 7.4.
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